December 11

Gov Accountability Project Creates "FactSquad" on Rx Drugs

Gov Accountability Project Creates “FactSquad” on Rx Drugs

December 11, 2005

In the wake of the credibility crisis public trust in the safety of FDA-approved prescription drugs is eroded. The Government Accounability Project (GAP) has established a “Fact Squad” to challenge poor performance; in particular,  FDA’s failure to protect the public from lethal drugs such as Vioxx. FDA’s so-called “gold standard”  have been shown to be nothing but   “Fool’s Gold.”

The Government Accountability Project is the nation’s leading whistleblower protection organization. Through litigating whistleblower cases, publicizing concerns and developing legal reforms, GAP’s mission is to protect the public interest by promoting government and corporate accountability.

AHRP commends GAP for taking the initiative in enlisting a worthy and formidable “Fact Squad” of experts.

Contact: Vera Hassner Sharav
veracare at ahrp org

DECEMBER 9, 2005
10:18 AM
CONTACT: Government Accountability Project
Dylan Blaylock, Communications Director
202.408.0034 ext. 137, cell 202.236.3733

Mark Cohen, Food & Drug Safety Director
202.408.0034 ext. 128

GAP Creates “Fact Squad” on Prescription Drugs

WASHINGTON – December 9 – The Government Accountability Project (GAP) has created a drug “Fact Squad” to serve as an independent resource for journalists seeking straightforward information on drug safety. The “Fact Squad” is composed of a list of experts on prescription drugs, pharmaceutical companies, and the government agency that regulates them. The experts on our “Fact Squad” are individuals who work to serve the public interest.

It has been shown that a growing number of Americans no longer trust the pharmaceutical industry. Simultaneously, there is a crisis of confidence in the Food & Drug Administration (FDA) as an impartial arbiter of drug safety and effectiveness. More than half of the agency’s drug budget comes from industry user fees earmarked for speeding up the approval of drugs. As a result, it has been suggested that the FDA, long established as the “gold standard” of consumer protection against industry’s dangerous drugs, now treats the industry as its primary client.

Our experts include:

Dr. John Abramson, MDDr. Abramson teaches primary care at Harvard Medical School. He has worked as a family doctor and has served as chairman of the department of family practice at Lahey Clinic. He was a Robert Wood Johnson fellow and is author of Overdosed America. He is an expert regarding commercial influences over medical research and medical knowledge, direct to consumer advertising, and the high cost and poor performance of the American health care system. Specific issues of interest include cox-II inhibitors, antidepressants, and Nexium, as well as the inappropriate focus on lowering cholesterol with statin drugs rather than promoting healthy lifestyle change to prevent heart disease.

Dr. David Antonuccio, PHD

Dr. Antonuccio is a clinical psychologist and member of the Nevada State Psychological Association. He is a professor of Psychiatry and Behavioral Sciences at the University of Nevada, School of Medicine. He has testified before the FDA and has authored multiple peer-reviewed articles. He is an expert in clinical psychology specializing in the treatment of depression, anxiety, sexual dysfunction, and smoking cessation.

Dr. Otis Brawley, MD

Dr. Brawley is Professor of Hematology, Oncology, and Medicine at the Emory University School of Medicine and Professor of Epidemiology at the Emory Rollins School of Public Health. He also serves as Associate Director of the Winship Cancer Institute at Emory University. In addition Dr. Brawley is Chief of Hematology and Oncology Services and the Medical Director of the Georgia Cancer Center for Excellence at Grady Health System. He has previously served as Assistant Director of the National Cancer Institute for the Office of Special Populations Research and was a Senior Investigator in the Division of Cancer Prevention and Control at the National Cancer Institute. He is the recipient of numerous awards to include the U.S. Surgeon General’s Medal and has been named a Georgia Cancer Coalition Eminent Scholar. Dr. Brawley is an expert in the screening, epidemiology, diagnosis, prevention and treatment of hormonal cancer. He has additional interests in the design of clinical trials, inclusion of minorities in trials and the availability of state-of-the-art health care to the socio-economically disadvantaged.

Dr. Howard Brody, MD, PHD

Dr. Brody is a professor of family practice and in the Center for Ethics and Humanities in the Life Sciences, College of Human Medicine, Michigan State University. He served as the director of the Center from 1985-2000. He also is a professor of philosophy at MSU, maintains a part-time clinical practice, and teaches medical students and residents. He is a member of the Institute of Medicine and the National Academy of Sciences. Dr. Brody has authored numerous books including Stories of Sickness and The Healer’s Power. He is an expert in medical ethics and the relationship between medicine and the pharmaceutical industry.

Dr. Curt Furberg, MD, PHD

Dr. Curt Furberg is professor of Public Health Sciences at the Wake Forest University School of Medicine and serves as the senior advisor to the dean for Health Services Research and Health Policy. Previously, he worked at the National Heart, Lung and Blood Institute where he served as Chief, Clinical Trials Branch. Dr. Furberg is co-author of a leading text book on clinical trial methodology, Fundamentals of Clinical Trials. He is also co-author of a new text book, Data Monitoring in Clinical Trials: A Case Studies Approach, and has published more than 350 articles. Dr. Furberg is a well-known cardiovascular epidemiologist with expertise in clinical trials, drug evaluation, drug safety, and the pricing of drugs. He is a member of the FDA Advisory Committee on Drug Safety and Risk Management.

Dr. David Graham, MD, MPH

Dr. Graham is the associate director of the Office of Drug Safety at FDA. In his 20 years at FDA he has challenged the safety of 12 drugs, of which 10 were removed from the market, including Vioxx. He has received numerous awards including the Award for Excellence from the American Public Health Association, the Joe A Callaway Award for Civic Courage from the Shafeek Nader Trust for the Community Interest, and the Cliff Robertson Sentinel Award from the Association of Certified Fraud Examiners. Dr. Graham graduated from the John Hopkins University School of Medicine and did residencies at Yale and the University of Pennsylvania. He has expertise in epidemiology, the testing and review of drugs, and an extensive knowledge on the inner workings of FDA. Dr. Graham is a GAP client.

Dr. David Healy, MD, FRCPsych

Dr. Healy is a professor of psychological medicine at Cardiff University of Wales in the UK. He is one of Europe’s eminent scientists and is renowned for his work with anti-depressant drugs. He has lectured around the world and has authored 13 books. His expertise includes Selective Seratonin Re-uptake Inhibitors, such as Prozac, and the fields of psychopharmacology and psychiatry.

Dr. David Himmelstein, MD

Dr. Himmelstein is an associate professor of medicine at Harvard Medical School. He practices primary care internal medicine and serves as chief of the Division of Social and Community Medicine at Cambridge Hospital in Cambridge, MA. He co-founded Physicians for a National Health Program (PNHP) and is the co-director of the Center for National Health Program Studies at The Cambridge Hospital and Harvard Medical School. He is an expert in health policy, access to health care, health care reform, and internal medicine.

Dr. Jerome Hoffman, MD

Dr. Hoffman is professor of medicine and emergency medicine at the University of California at Los Angeles School of Medicine. He is a health services researcher, who also served as director of the UCLA Doctoring Program for over 10 years. Dr. Hoffman is an expert in clinical epidemiology, critical appraisal (the technique of evaluating medical literature critically and appropriately to assist medical practice), and the influence of drug companies on physicians, health care entities (medical journals, universities, research organizations), and public policy.

Dr. John Jureidini, PHD, FRANZCP, MBBS

Dr. Jureidini is the head of the Department of Psychological Medicine at the Women and Children’s Hospital of Adelaide, South Australia. He is a clinical senior lecturer in the department of psychiatry at the University of Adelaide and a senior research fellow in the Department of Philosophy at Flinders University of South Australia. He is an expert in depression in children, ADHD, dissociation, and chronic illness in children.

Dr. Allen Shaughnessy, PharmD

Dr. Shaughnessy is a board certified pharmacotherapy specialist and is a fellow of the American College of Clinical Pharmacy. He is an adjunct professor of public health and family medicine at Tufts University School of Medicine and teaches in the Tufts University Family Medicine Residency. He co-developed the concept of “Patient-Oriented Evidence that Matters,” which focuses on finding and evaluating information that directly affects the health and well-being of patients. Dr. Shaughnessy is an expert in evidence-based medicine, pharmacology, clinical information management by physicians, and the interaction between physicians and the pharmaceutical industry.

Dr. Michael Wilkes, MD, PHD

Dr. Michael Wilkes is vice dean for medical education and a professor of medicine at the University of California at Davis. He is an award-winning teacher and has worked in a host of countries as a consultant in curriculum development. He is an NIH and CDC funded researcher studying the dissemination of information, physician practice behaviors, and use of new technology and pharmaceuticals. He is also the head of the Adolescent Medicine Unit at the University Hospital. He has testified in front of the House Government Reform Committee and has been a medical commentator on NPR for the past 15 years. He has expertise in drug policy, physician education, cancer screening, clinical epidemiology, general internal medicine, and adolescent medicine.

Dr. Steffie Woolhandler, MD, MPH

Dr. Woolhandler is an associate professor of medicine at Harvard Medical School and is co-director of the Harvard Medical School General Internal Medicine Fellowship Program. She practices primary care internal medicine at Cambridge City Hospital, and co-founded and is a board member of Physicians for a National Health Program (PNHP). She is an expert on administrative waste, health policy, access to health care, health care reform, and internal medicine.

The “Fact Squad” is also available on GAP’s Web site at GAP has compiled this group of experts with the guidance of investigative journalist Jeanne Lenzer.

Government Accountability Project

The Government Accountability Project is the nation’s leading whistleblower protection organization. Through litigating whistleblower cases, publicizing concerns and developing legal reforms, GAP’s mission is to protect the public interest by promoting government and corporate accountability. Founded in 1977, GAP is a non-profit law firm with offices in Washington, D.C. and Seattle, WA.

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